Enforcement Report - Week of October 2, 2013

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Product Detail

Product Description

ABX PENTRA Calcium CP Reagent, Model # A11A01633
Calcium plays an essential role in many cell functions: intracellularly in muscle contraction and glycogen metabolism, extracellularly, in bone mineralization, in blood coagulation and in transmission of nerve impulses. Calcium is present in plasma in three forms: free, bound to proteins or complexed with anions as phosphate, citrate and bicarbonate. Under physiological conditions, calcium balance is determined by the relationship between calcium intake and calcium absorption and excretion. Urinary excretion is an important determinant of calcium retention in the body. Decreased total calcium levels can be associated with diseases of the bone apparatus (especially osteoporosis), kidney diseases (especially under dialysis), defective intestinal absorption and hypoparathyroidism. Increased total calcium can be measured in hyperparathyroidism, malignant diseases with metastases and sarcoidosis. Calcium measurements also help in monitoring of calcium supplementation mainly in the prevention of osteoporosis.

Recall Number

Z-2280-2013

Classification

Class III

Code Info

Lot/Serial #(s): 014664503

Product Distributed Qty

2,658 units ( 1240 US 1418 OUS )

Reason For Recall

HORIBA Medical is informing all PENTRA 200 and PENTRA 400 customers of a potential for reporting
incorrect calcium results when using the ABX PENTRA CALCIUM CP reagent.